Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3840_Библиотеки_им_академика_М_И_Перельмана
.pdf
(A)
(B)
(C) (D)
Criss-cross
(E) (F)
Figure 5 The Twin-RailTM(A) is a double balloon, dual lumen rapid exchange system that tracks over two wires.
Panel (B) demonstrates an expanded Twin-Rail
lesion of the left circumflex (LCX) and a large obtuse marginal (OM). Both branches of the bifurcation were wired
and then predilated. The Twin-Rail was then delivered over two wires through the guiding catheter but wire wrap
prevented advancement to the bifurcation (E and F). A third protection buddy wire was placed in the OM before
removing the twisted wire and rewiring the OM. Panel (G) confirms the absence of wire wrap. The device was
then advanced to the carina and deployed by simultaneous dual balloon inflation (using a single indeflator) while
pushing on the system (H). The system is retracted and access to both branches is preserved. Final kissing
postdilatation was then performed (I). Panel (J) shows the final angiographic result.
Dr. Remo Albiero.
TM
stent. Baseline angiography (C and D) shows a true bifurcation
Source
: Photos courtesy of
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
(G) (H)
221
(I) (J)
Figure 5 (
and there was a high rate of guidewire crisscross with both devices. The TLR rate for the TwinRail
device success and better safety profile with the Twin-Rail
SDS. The second-generation Twin-Rail
Germany, by Hoffman et al. in 41 patients between April and September 2005 (Table 2) (15,16).
The Twin-Rail
Continued
TM
was 14.3% at seven months. In this small pilot study, there was also a trend for higher
)
TM
TM
was then assessed in a single-center registry in Berlin,
TM
was also assessed in a single-center randomized trial, which compared this
compared to a single balloon
dedicated stent to provisional stenting with a conventional bare-metal stent (Libert´e
Scientific) in 60 patients with de novo bifurcation disease (17). The use of the Twin-Rail
associated with reduced procedure and fluoroscopy time (34 ± 9vs.46± 20 min, p = 0.004;
and 9 ± 6vs.15± 9 min; p =0.003, respectively) and lower contrast volumes (168 ± 86 mL vs.
199 ±103 mL; p=0.02). At12-month follow-up,there wereno statisticallysignificant differences
regarding TLR (14% vs. 13%) or MACE (13.7% vs. 13.3%; p =0.9).
TM
;Boston
TM
was
222
LATIB ET AL.
Nile CroCoTM(Minvasys)
The Nile CroCo
Twin-Rail
Nile CroCo
TM
TM
TM
(Fig. 6) is a double balloon SDS similar to the Multilink FrontierTMand
but unlike these latter SDS’s that are a single catheter with single inflation port, the
has two independent yet joinedcatheters that require independent manipulation
and pressure monitoring. The two parallel rapid exchange catheters are premounted with a
chromium cobalt stent crimped on the MB balloon and the tip of the SB balloon. The MB
balloon has three markers with the central marker indicating the position of the SB aperture.
After thestent is deployedinto the MB, theSB balloon is advancedinto the SBand a final kissing
inflation is performed with the deploying balloon and the tapered SB balloon to limit proximal
overexpansion.
The feasibility, safety, and efficacy of bifurcation stenting using the Nile
TM
CroCo
uated the first-generation 316 L stainless steel Nile
stent have been evaluated in two multicenter registries. Lefevre and colleagues eval-
TM
stent in the multicenter (10 European
TM
and Nile
centers) Nile Registry (18). Preliminary results of the first 75 patients showed a procedural success rate of 94.7% and aMACE rate of 10.7%in the 45 patientsin whom follow-up wasavailable
at seven months. The second-generation Nile CroCo
TM
stent, made from a 605-L chromium
cobalt alloy, was then assessed in the three-center Spanish-French Nile CroCo Registry (19).
The promising acute and mid-term results of these first- and second-generation dedicated
stents prompted the development of a drug-eluting version based on the chromium cobalt Nile
TM
CroCo
surface with 2.5 g/mm
the drug is released within 45 days with complete reversion to a cobalt chromium stent (20).
Minvasys have also developed a specific SB stent (Nile Delta
designed to fit with their MB stent. The Delta
shaped balloon, similar to the SB balloon of the Nile CroCo
platform.
The Nile Pax
TM
is a polymer-free dedicated bifurcation stent coated only the abluminal
2
of paclitaxel. As a result of the polymer-free delivery of paclitaxel, all
TM
TM
is a short 8 mm stent mounted on a conical
—BMS and Delta PaxTM—DES)
TM
. Using the MB balloon with the
(A) (C)(B)
Figure 6 The Nile CroCoTM(A) is a doubleballoon, duallumen rapidexchange systems that has two independent
catheters (
stent (B). The Nile Delta
the SB ostium without leaving a gap (C). Baseline angiography of a 74-year-old male with a true bifurcation lesion
of the posterior descending (PDA) and posterolateral (PL) arteries (D and E), who underwent bifurcation stenting
with the Nile CroCo
CroCo
MB (PDA) balloon aligned with the center of the SB (PL) ostium (F). The Nile CroCo
PDA (G) and the SB balloon was then advanced into the PL and positioned by aligning the proximal marker of
the SB balloon with the middle marker of the MB balloon (H). Final kissing inflation with two indeflators was then
performed (I). The Nile Delta
PL (J), and final kissing inflation was repeated (K). The final angiographic result was excellent (L).
arrows
) that can be manipulated and inflated separately to deploy the Nile CroCoTMSB access-MB
TM
is an SB stent specifically designed to be implanted after the Nile CroCoTMand cover
TM
TM
(3.5 mm MB/2.5 mm SB × 18 mm) was positioned at the bifurcation site with the middle marker of the
and Nile DeltaTM. Both branches of the bifurcation were wired and predilated. The Nile
TM
was then deployed on the
TM
was then positioned and implanted with the proximal marker at the ostium of the
(
Continued on pages 223 and 224
)
(D) (E)
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
(F) (G)
(H) (I)
Figure 6 (
Continued
)
224
LATIB ET AL.
(J)
(K) (L)
Figure 6 (
Nile DeltaTMor Delta PaxTMshould avoid any potential gap when placing the additional stent
in the SB. The safety and efficacy of the Nile Pax
Continued
)
TM
and Delta PaxTMis currently being assessed
in a prospective, nonrandomized, multicenter BiPAX (Bifurcation Paclitaxel-Eluting Stent) trial.
The BiPAX trial will enroll 100 de novo bifurcation lesions with the primary endpoint of binary
angiographic restenosis of the MB and SB at nine months after the procedure.
TM
AST SLK-View
The SLK-View
(Advanced Stent Technologies, Pleasanton, CA)
TM
(Fig. 7) is a 316-L stainless steel flexible slotted tube stent with a side aperture
located between the proximal and distal sections to facilitate access to the SB after deployment
of the stent in the MB. The delivery system has a dual over-the-wire design with a proximal
dual lumen shaft that separates into two catheters (a balloon and a side-sheath) at its distal
segment. The stent is premounted on the distal segment of delivery system with the side-sheath
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
225
(A) (B)
Figure 7 The SLK-viewTMis a MB stent with a preformed aperture (A), without stent struts that scaffold the
ostium, that has to be positioned accurately at the ostium; the stent is mounted on a dual over-the-wire stent
delivery system that separates into a side sheath and balloon distally; the side sheath runs under the stent and
positions the side hole at the ostium (B).
running under the proximal segment of the stent and exiting through the side hole. There are
a total of three radiopaque markers on the balloon located at the center, proximal, and distal
edges. The SLK-View
bifurcation until the center marker band is aligned to the branch vessel and the side sheath
marker separates from the center marker. The SLK-View
leaving the preformed side hole positioned at the ostium. Unlike the Petal
stents, there are no stent struts protruding into and scaffolding the ostium.
The SLK-View
TM
system is placed over two wires simultaneously and advanced to the
TM
stent is then deployed on the MB
TM
stent has been assessed in a multicenter nonrandomized study of 81
TM
or Antares
TM
patients with 84 de novo bifurcation lesions (21). The study proved the feasibility of this stent
with high procedural success rates (97.6%) while maintaining SB access in all treated lesions.
However, the SLK-view
TM
bare-metal stent was associated with a high restenosis (MB: 28.3%,
SB: 37.7%) and TLR rate (21%) at six-month follow-up. However, this stent has been removed
from the market and is not under investigation anymore since the company has been acquired
by Boston Scientific, which slightly modified the stent creating the Petal
TM
stent system.
TM
Stentys
The Stentys
next-generation bifurcation stents. The current drug-eluting version of Stentys
the abluminal sidewith Paclitaxel (0.8 g/mm
polymer matrixof polysulfone (PESU) and solublepolyvinylpyrrolidone (PVP)as the excipient]
that permits controlled drug elution (22,24). The Stentys
(Stentys S.A.S., Clichy, France)
TM
bifurcated bare-metal or drug-eluting stent (22–24) (Fig. 8) is the first of the
2
of stent) incorporatedin ProTeqtor
TM
is a provisional, self-expanding
nitinol stent made of Z-shaped struts linked by small interconnections that can be disconnected
in prespecified points every 1.5 mm all around the circumference and the length of the stent
except for the most proximal and distal 2.5 mm segments (22,24). The unique feature of this
stent is the ability to disconnect these stent struts with an angioplasty balloon. Thus an opening
for the SB can be created anywhere in the stent after it is implanted in the vessel while the
disconnected struts scaffold the SB ostium. In comparison to the implantation of some of the
other bifurcation stents such as the Petal
dependant on accurate positioning of the stent, and there is significant placement tolerance
with the Stentys
TM
. However, it would appear from thedesign that the disconnected struts only
TM
and the AntaresTM, the procedural success is not
partially scaffold the ostium.
The implantation procedure is performed in three steps: (i)Stentys
the MB with an approximate positioning, like a standard stent; (ii) optimal location for the
SB opening is chosen by inserting a balloon through the stent mesh; (iii) the balloon inflation
disconnects the mesh and creates the opening. Maximum ostial coverage is best achieved with
bifurcating angulations of 30 degrees to 70 degrees by opening of the cell closest to the carina.
It is hoped that the self-expanding property of the stent will allow in-situ modeling of the stent
TM
is coated on
R
[a durable
TM
is implanted in
Self-expanding
nitinol
Excellent ostium
coverage with SB
stent
Anatomical reconstruction of
Excellent SB
access
the bifurcation shape
(A)
Positioning
tolerance
(disconnectable
struts on full length)
Distal MB
stented
Figure 8 (A) The design features of the StentysTMand inset demonstrating electron microscopy of a cleanly
disconnected strut. (B) The deployment sequence of the Stentys
(B)
TM
: StentysTMis implanted in the MB over a
single wire, like a standard stent, without specific positioning related to the SB; if access or treatment of the SB
is required, a guidewire and a balloon are advanced through the stent mesh; a low-pressure balloon inflation
disconnects the connectors and creates the opening—the self-expanding property allows in situ modeling of the
stent. Baseline angiography (C, right anterior oblique cranial view; D, left anterior oblique cranial view) of the left
coronary artery showing a moderate-to-severe stenosis in the mid-left anterior descending artery just after the
origin of the first diagonal branch (in the white circles). Positioning of the Stentys
TM
coronary bifurcation system at
the level of the lesion in the mid-left anterior descending artery, over the ostium of the first diagonal branch (E). (F)
The single wire 5F delivery system: the stent is delivered in the MB by means of a covering sheath that is retracted
at the moment of deployment; the delivery system has a marker on the end of the sheath and on the stent stopper
to facilitate easy deployment. Passage of a second coronary wire into the diagonal branch through the Stentys
struts in the cell closest to the carina (G). StentBoost Subtract imaging of the Stentys system after deployment
in the left anterior descending artery, before balloon angioplasty of the ostium of the side branch, showing good
conformability of the stent to the anatomy of the bifurcation (H). StentBoost Subtract after balloon angioplasty of
the ostium of the diagonal branch, showing a gapin the angiographic ‘‘profile’’ of the Stentys system(
white arrow
),
which indicates an effective disconnection of the struts at the level of the bifurcation (I). Final angiographic results
(J and K), with “step-up” and “step-down” phenomena at the proximal and distal edge of the stent, respectively,
because of the self-expanding property of the stent itself.
Source
: Adapted from Ref. 38.
(
Continued on pages 227 and 228
)
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
(C) (D)
227
(E) (G)
(F)
Figure 8 (
Continued
)
228
(H)
(I)
LATIB ET AL.
(J) (K)
Figure 8 (
Continued
)
to fit the patient’s unique arterial anatomy and that the superelastic properties of nitinol as well
as the fact that the disconnections are created in prespecified points would prevent permanent
strut deformation. However, it is not known if the StentysTMis more prone to stent fracture due
to its disconnectable strut design.
A multicenter FIM study hasbeen completedto evaluate thesafety and efficacyof theSten-
tys in de novo bifurcation lesions. The Stentys
TM
OPEN I study (Stentys Coronary Bifurcation
Stent System fOrthePErcutaNeous treatment of de novo lesions in native bifurcated coronary
arteries), enrolled a total of 40 patients between September 2007 and September 2008 in nine
European clinical sites. The primary endpoint was the procedural success that was defined as
technical and angiographic success in the absence of a major adverse cardiac event (MACE) at
hospital discharge (23,24). Procedural success was achieved in 39 of 40 cases and the only case
of device failure was due to inability to track the stent in one patient with an extremely tortuous
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
229
vessel. In total 6 (15%) paclitaxel-eluting and 33 (85%) BMS StentysTMstents were successfully
implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved
in 37 (94.9%) of 39 cases. In two cases, disconnection was not attempted, as the Stentys
TM
had
been malpositioned to distal to the bifurcation, and thus the nondisconnectable proximal end
of the stent was covering the SB ostium (23,24). The MACE at 30 days was 5% as a result of
one non–Q-wave MI following the procedure and one ischemia-driven revascularization six
days after the procedure. At six months, the MACE had increased 25% (10 of 40), and this was
predominantly accounted for by a further eight clinically driven TLR. The late lumen loss in
the 30 bare-metal Stentys
IVUS substudy confirmed excellent stent apposition at six months, with an increase in mean
minimum stent cross-sectional area from 7.93 ± 1.33 mm
TM
was 0.85 ± 0.63 mm, which is similar to a conventional BMS. An
2
to 11.55 ± 2.12 mm2at six months,
suggesting a type of “chronic gain” in keepingwith the self-expanding properties of this nitinol
stent (23,24).
TM
Petal
SB occlusion caused by vessel deformation and plaque shift remains a concern with current
approaches to bifurcation PCI. The Petal
(Boston Scientific)
TM
stent (Fig. 9), with a side aperture located mid-stent
and deployable struts (a “sleeve”), may be an attractive solution to prevent SB occlusion after
MB stenting. A guidewire is placed in the MB and another in the SB. The dual side-exchange
(double balloon) delivery system has a main lumen that guides the catheter to the primary
lesion over the MB guidewire. The secondary lumen (side sheath) facilitates proper albeit
passive rotational alignment of the aperture to the SB ostium as it tracks over the SB guidewire.
The SDS has four marker bands (two smaller markers on SB balloon and two larger markers
on MB balloon) to ensure correct alignment. In addition to a conventional cylindrical-shaped
balloon, thereis a secondary elliptical balloon adjacent tothe main balloon andconnected to the
same inflation lumen so that a single inflation device is needed. The Petal
TM
stent is crimped
over both balloonssuch that the elliptical balloonis under the side aperture and petal elements.
Upon inflation, the main balloon deploys the stent into the MB, whereas the elliptical balloon
deploys the petal elements into the SB ostium. The purpose of the “petal” aperture is to retain
access to the SB during and after deployment and to scaffold the SB ostium with outwardly
deploying strut elements that extend up to 2 mm into the branch during deployment. This
unique feature has potential for delivery of antiproliferative drug to the most common site of
bifurcation restenosis. The projecting petal elements facilitate the placement of a stent in the SB
without gaps in scaffolding or drug application, and so may reduce restenosis.
The first-generation of this stent, called AST Petal
nologies was a 316 L stainless steel slotted tube design. In a FIM study, the AST Petal
TM
, developed by Advanced Stent Tech-
TM
was
successfully implanted in 12 of 13 patients with the one failure due to inability to advance the
device after vessel dissection from predilatation (25). Of note, in another four patients, device
delivery was temporarily impeded by wire wrap (three cases) and incomplete device rotation
(one case). In nine patients, an additional stent was required in the bifurcation and the TLR rate
was 15% (2 of 13) at six months. The Petal
and modified into the Taxus Petal
TM
chromium alloy stent, which is coated with Paclitaxel on a Translute polymer [poly(styrene-b-
isobutylene-b-styrene)], which is the same polymer currently utilized by the Taxus
TM
stent was acquired by Boston Scientific in 2004
stent. This second-generation PetalTMstent is a platinum
TM
stent. The
platinum chromium is superior to its stainless steel predecessor in that the new alloy allows
even thinner stent struts with increased flexibility and radiopacity.
The Taxus Petal
TM
stent is currentlyunder investigationin aFIM trialto assessthis device’s
acute performance and safety (death, myocardial infarction, target vessel revascularization) at
30 days and 6 months, as well as continued annual follow-up for 5 years. The main inclusion
criteria are de novo bifurcation lesions with a bifurcation angle between 30 degrees and 90
degrees and disease length limited to 20 mm MB and 14 mm SB. The Taxus Petal
TM
was
successfully deliveredin 25 of the 28patients in the FIM trial,but the implant success per device
was 73.5% (25 of 34), as it was not possible to deliver nine stents (26). Main reasons for device
failure were wire wrap andwire bias, which madeit challenging toachieve rotational alignment
with the Petal
TM
stent in some cases. The primary endpoint (30-day death, MI, TVR) occurred
Соседние файлы в папке Библиотека им академика М.И. Перельмана